MOXIWAR 400 (Moxifloxacin Tablets 400mg)

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

MOXIFLOXACIN HCL

Доступна з:

HEALOL PHARMACEUTICALS SDN. BHD.

ІПН (Міжнародна Ім'я):

MOXIFLOXACIN HCL

Одиниць в упаковці:

2 x 5tablet Tablets

Виробник:

Aurobindo Pharma Limited, Unit-VII (SEZ)

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MOXIWAR 400 (MOXIFLOXACIN TABLETS 400MG)
Moxifloxacin Hydrochloride (400mg)
1
WHAT IS IN THIS LEAFLET
1.
What MOXIWAR 400 is used
for
2.
How MOXIWAR 400 works
3.
Before you use MOXIWAR 400
4.
How to use MOXIWAR 400
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
MOXIWAR 400
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS MOXIWAR 400 USED FOR
MOXIWAR 400 is used to treat
bacterial infections in adults (≥18
years old) caused by susceptible
strains of bacteria. This medication is
usually used to treat the infections
listed below:
•
Acute sinusitis
(inflammation of your
sinuses).
•
Sudden flare ups of chronic
bronchitis (inflammation of
your lung airways)
•
Community
acquired
pneumonia (lung infection)
•
Mild to severe inflammatory
pelvic disease (infections of
the upper female genital
tract)
•
Complicated skin and skin
structure infections
•
Complicated intra-
abdominal infections
including abscesses
HOW MOXIWAR 400 WORKS
Moxifloxacin is a broad spectrum
antibiotic which kills many types of
bacteria. It inhibits a type of enzyme
in the bacteria, stopping it from
forming new bacterial cells.
BEFORE YOU USE MOXIWAR 400
-When you must not use it
It is important to tell your doctor
before taking MOXIWAR 400 in
case of hypersensitivity to
moxifloxacin or other quinolone type
antibiotics or any of the excipients
contained in this product. The use of
moxifloxacin in patients below 18
years of age is not recommended.
Please seek your doctor or
pharmacist’s advice before taking
this medication if:
•
You had a history of tendon
disease/ disorder with use of
antibiotics.
•
You are pregnant or
breastfeeding.
•
You have heart related
health problems (e.g.
abnormal heart beat, slow
heartbeat, heart failure)
•
You have impaired liver
function.
•
You have electrolyte
imbalances (potassium
imbalance).
-Before you start to use it
It is important to tell your doctor
before taking MOXIWAR

Характеристики продукта

NAME OF DRUG PRODUCT
:
Moxifloxacin Tablets 400 mg
(TRADE) NAME OF PRODUCT
:
MOXIWAR 400
STRENGTH
:
400 mg
PHARMACEUTICAL DOSAGE FORM : Film-coated Tablet.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains Moxifloxacin Hydrochloride Ph.Eur.
equivalent to Moxifloxacin 400 mg.
PHARMACEUTICAL FORM:
Dull red colored, modified capsule shaped film-coated tablets debossed
with “E 18” on one side and plain on the other side.
ROUTE OF ADMINISTRATION: Oral
CLINICAL PARTICULARS:
THERAPEUTIC INDICATIONS:
Moxifloxacin tablets are indicated for the treatment of adults (> 18
years of age) with the following bacterial infections caused by
susceptible
strains:
•
Acute sinusitis
•
Acute exacerbation of chronic obstructive pulmonary disease including
chronic bronchitis*
*MOXIWAR 400 should be only used:
When Pseudomonas is considered AND patient is allergic to
antipseudomonal penicillins/cephalosporins;
For resistant organisms with no other alternative antibiotics
available.
•
Community acquired pneumonia
•
Mild to moderately severe inflammatory pelvic diseases (i.e.
Infections of the upper female genital tract, including salpingitis
and endometritis), without an associated tubo-ovarian or pelvic
abscess. Moxifloxacin tablets 400 mg are not recommended for
monotherapy of mild to moderately severe inflammatory pelvic diseases.
Preferably, they should be administered in combination with
another suited antibiotic (such as cephalosporin), due to the
increasing resistance of Neisseria gonorrhoeae to moxifloxacin; that
is,
unless moxifloxacin-resistant Neisseria gonorrhoeae can be ruled out.
•
Complicated skin and skin structure infections
•
Complicated intra-abdominal infections including polymicrobial
infections such as abscesses
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
POSOLOGY AND METHOD OF ADMINISTRATION:
POSOLOGY
_ADULTS: _The recommended dose for Moxifloxacin is 400mg once daily (1
film-coated tablet) for the above mentioned indicati